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Abstract

Introduction: The Medtronic Sprint Fidelis (SF) implantable cardioverter-defibrillator (ICD) lead has a higher than expected failure rate. Because of patient safety, Medtronic announced two advisories consisting of

adjustments in device settings (October 2007) and

installation of a lead integrity algorithm (May 2008).

Objective: To evaluate the effect of Medtronic’s advisories on patient safety.

Methods: To comply with the advisories, two recalls were conducted. The effect of the recalls was assessed by the lead failure rate and the occurrence of inappropriate shocks due to lead failure. Three periods were distinguished in the comparison of event rates: lead implantation to first advisory (period A), in-between both advisories (period B) and second advisory to follow-up (period C).

Results: Since 2004, 372 patients received a Medtronic ICD and SF lead and were followed from first implant (December 2004) to April 2009. The incidence of lead failure per 100 lead-years was 1.9 [95% CI 0.86, 3.55] in period A, 3.2 [95% CI 1.54, 5.91] in period B and 3.1 [95% CI 0.83, 7.82] in period C. After implementation of both advisories, the occurrence of inappropriate shocks due to lead failure decreased from 1.5 [95% CI 0.59, 3.00] per 100 lead-years in period A to 0.8 [95% CI 0.02, 4.25] per 100 lead-years in period C (Figure⇓).

Conclusion: The current study demonstrates that despite an increasing risk for SF lead failure, implementation of the advisories decreased the occurrence of inappropriate shocks due to lead failure.